20 results
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74ms
·
Sources: EU EUDAMED, US FDA
FLOSEAL MATRIX HEMOSTATIC SEALANT
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code LMF·July 10, 2002
FLOSEAL MATRIX HEMOSTATIC SEALANT
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code LMF·January 12, 2001
FLOSEAL HEMOSTATIC SEALANT
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code LMF·January 12, 2001
FLOSEAL MATRIX HEMOSTATIC SEALANT
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code LMF·June 17, 2002
FLOSEAL MATRIX HEMOSTATIC SEALANT
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code LMF·June 17, 2002
FLOSEAL MATRIX HEMOSTATIC SEALANT
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code LMF·April 12, 2002
FLOSEAL MATRIX HEMOSTATIC SEALANT
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code LMF·April 12, 2002
FLOSEAL MATRIX HEMOSTATIC SEALANT
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code LMF·April 12, 2002
FLOSEAL MATRIX HEMOSTATIC SEALANT
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code LMF·April 12, 2002
FLOSEAL MATRIX HEMOSTATIC SEALANT
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code LMF·April 12, 2002
FLOSEAL MATRIX HEMOSTATIC SEALANT
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code LMF·April 12, 2002
RAPISEAL PATCH
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code FTL·November 11, 1997
FLOSEAL MATRIX HEMOSTATIC SEALANT
FDA Adverse Event
Injury
·FUSION MEDICAL TECHNOLOGIES, INC.·Product code LMF·July 20, 2001
Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only.
FDA Enforcement
Class II
·Terminated·PROVIDENCE MEDICAL TECHNOLOGIES·July 1, 2020
VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcots Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code HSB·April 5, 2012
ENDO-FUSE(TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005950, LOT 088605355, IMPLANT MATERIAL: Wright Medical Technology, Inc , 5677 Airline Road, Arlington, TN 38002 The ENDO-FUSE(R) Intra-Osseous Fusion Rods are indicated for the reduction and fixation of fractures. They are indicated for the integral fixation of fractures, bony fusions, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code HWC·April 20, 2011
ENDO-FUSE(TM) FUSION ROD, 7 mm X 70 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005970, LOT 088605422, Wright Medical Technology, Inc , 5877 Airline Road, Arlington, TN 38002 The ENDO-FUSE(R) Intra-Osseous Fusion Rods are indicated for the reduction and fixation of fractures. They are indicated for the integral fixation of fractures, bony fusions, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code HWC·April 20, 2011
VALOR(R), TARGETING GUIDE, REF 4150011000, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcots Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code HSB·April 5, 2012
Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only.
FDA Recall
Terminated
·PROVIDENCE MEDICAL TECHNOLOGIES·Product code HWC·March 29, 2019
M/L Taper with Kinectiv Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
FDA Recall
Terminated
·Zimmer, Inc.·Product code KWA·May 18, 2015